Quantification of Dabigatran in Spiked Human Plasma in Bulk and Formulations as Per M10 Guidelines by Spectroscopic Technique

ABSTRACT: Our research indicates that chromogen method has beendeveloped fordabigatran, however, for plasma analysis we incorporated a chromogenic approach specifically for dabigatran in plasma. To ensure a simple and accurate assessment, a spectrophotometric technique has to be developed and validated for for the quantiifcation ofdabigatran etexilate mesylate (DAB) in bulk and pharmaceutical dose forms. This method uses the 1-Naphthol reagent, which yields a colored complex facilitating precise measurement.To develop a novel, straightforward, accurate, repeatable, and exact chromogenic UV-visible spectroscopy, and bioanalytical technique, for measuring dabigatran etexilate mesylate in pharmaceutical formulations and bulk. In the presence of Sodium Nitrite and HCl with Ammonium Sulfamate, amine undergoes diazotization. DAB and 1-Naphthol react to generate a green complex that can be detected at 449 nm. Chromogenic method was used for quantification of dabigatran in incurred plasma and quality control samples. Method development and validation for quantification of dabigatran was developed and validated.Human serum UV-visible spectroscopy was created and verified. Plasma was extracted with protein precipitation by acetonitrile. Recoveries for both incurred plasma and quality control sample exceeded 89.48% while accuracy fell below 101.26% and 101.96% respectively and RSD less than 10% each. Overall, we conclude that the method developed was sensitive and accurate for easy analysis of plasma incorporated with chromophore/reagent. The findings of results are more accurate data and validated as per proceeded guidelines i.e, M10.